|Número de publicación||US8041431 B2|
|Tipo de publicación||Concesión|
|Número de solicitud||US 12/350,080|
|Fecha de publicación||18 Oct 2011|
|Fecha de prioridad||7 Ene 2008|
|También publicado como||US20090177251|
|Número de publicación||12350080, 350080, US 8041431 B2, US 8041431B2, US-B2-8041431, US8041431 B2, US8041431B2|
|Inventores||Paul Huelskamp, Thomas J. Harris, Binh C. Tran, Ramprasad Vijayagopal|
|Cesionario original||Cardiac Pacemakers, Inc.|
|Exportar cita||BiBTeX, EndNote, RefMan|
|Citas de patentes (119), Citada por (2), Clasificaciones (7), Eventos legales (2)|
|Enlaces externos: USPTO, Cesión de USPTO, Espacenet|
This non-provisional patent application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent application Ser. No. 61/019,549, filed Jan. 7, 2008, the disclosure of which is incorporated by reference.
The invention relates in general to oscillator trimming and, specifically, to a system and method for in situ trimming of oscillators in a pair of implantable medical devices.
Implantable medical devices (IMDs) can provide in situ physiological data monitoring and therapy delivery, including cardiac defibrillation, pacing and resynchronization, and intracorporeal drug delivery. IMDs function through pre-programmed control over monitoring and therapeutic functions. As required, IMDs can be interfaced to external devices, such as programmers, repeaters, and similar devices, which can program, troubleshoot, and exchange parametric and physiological data through induction or other forms of wireless telemetry.
Implantable sensors monitor and relay physiological data to other devices. Advanced conventional IMDs can be interfaced with implantable sensors directly through wired interconnections, or indirectly via an external intermediary device. Wired interconnections are invasive and require an intrabody tunnel that exposes a patient to adverse side effects, including internal injury, infection, and discomfort. Relay through an external intermediary device requires the periodic upload of stored data, which is only then available to an IMD indirectly by separate download. Thus, the physiological data can go stale before receipt by the IMD.
Alternatively, IMDs can be directly interconnected for data exchange through a wireless intrabody network, such as described in commonly-assigned U.S. Patent Publication No. 2006/0031378, published Feb. 9, 2006, pending, the disclosure of which is incorporated by reference. Multiple IMDs exchange data wirelessly through acoustic or radio frequency (RF) connections. Wireless intrabody interconnection alleviates the need for large onboard storage for holding monitored data, which can instead be immediately exchanged between the multiple IMDs.
Effective wireless intra-IMD communications, though, require maintaining interconnected IMDs in synchrony. Digital components within each device are susceptible to factors affecting performance, such as temperature, age, mechanical and electrical tolerances, and operational environment. Oscillators, for instance, control the timing of IMD operations, but frequency drift, which occurs naturally over time, can skew an oscillator's timing, which in turn skews IMD operation. Similarly, transducers convert electrical signals into and from acoustic energy. Channel characteristics can degrade transducer efficiency. Oscillator frequency drift can further degrade transducer efficiency by skewing transducer operation away from a trim frequency. Conventional IMD synchronization fails to compensate for oscillator-precipitated transducer skew.
U.S. Pat. No. 6,823,031, issued Nov. 23, 2004, to Tatem, Jr., discloses automated frequency compensation for remote synchronization. An oscillator is stepped through offset frequencies that are associated with a lock range of a phase lock loop (PLL). Oscillator frequencies are incremented until a desired result is achieved, after which control reverts back to the PLL. However, the oscillator for a device is trimmed without transducer adjustment.
U.S. Pat. No. 7,187,979, issued Mar. 6, 2007, to Haubrich et al., discloses medical device synchronization with reduced reliance on periodic polling. The internal clocks of two devices, such as an IMD and an external device, can be synchronized by computing time drift as a function of measured skew. In a further embodiment, an IMD is synchronized to a time signal generated by an external time reference with polling performed only when a device is likely to be receptive. However, oscillator synchronization is reliant on an external reference signal and is trimmed without transducer adjustment.
Therefore, an approach is needed to provide intracorporeal trim of transducers of wirelessly interconnected IMDs. Preferably, such an approach would avoid significant depletion of resources.
The transducers in a pair of IMDs are trimmed through an intracorporeal frequency sweep of their respective oscillators. A search space of oscillator trim frequencies for each IMD is determined. An initiating IMD notifies a responding IMD to begin a sweep of the oscillator trim frequencies. Each IMD selects oscillator trim frequencies through a heuristic mapping of the search space. For each pair of selected oscillator trim frequencies, the initiating IMD repeatedly sends a command and monitors responses received from the responding IMD. The oscillator trim frequency pairing providing the strongest command exchange is selected to trim the transducers. Safe operation is assured by saving the responding IMD's new oscillator trim frequency into volatile memory to permit recovery of the original, albeit possibly non-optimal, oscillator trim frequency if subsequent communication with the initiating IMD fails.
One embodiment provides a system and method for in situ trimming of oscillators in a pair of IMDs. Each frequency over a range of oscillator trim frequencies for an initiating IMD is selected and a plurality of commands are sent via an acoustic transducer in situ over the frequency selected. Each frequency over a range of oscillator trim frequencies for a responding IMD is selected and a response to each of the commands received is sent via an acoustic transducer in situ over the frequency selected. The responses received by the initiating IMD are evaluated and a combination of the oscillator trim frequencies for both IMDs that together exhibit a strongest acoustic wave is identified. Oscillators in both IMDs are trimmed to the oscillator trim frequencies in the combination identified.
A further embodiment provides a system and method for intracorporeal trimming of acoustic transducers for a plurality of interconnected IMDs. A two-dimensional search space is mapped and includes a range of oscillator trim frequencies for an initiating and a responding IMD. On the initiating IMD, a sweep of the oscillator trim frequency ranges is performed that includes selecting each oscillator trim frequency in the search space, and sending a series of commands to the responding IMD at the selected oscillator trim frequency via an acoustic transducer. On the responding IMD, a sweep of the oscillator trim frequency ranges is also performed that includes selecting each oscillator trim frequency in the search space, and sending a response to each command that is received to the initiating IMD at the selected oscillator trim frequency via an acoustic transducer. The responses received by the initiating IMD from the responding IMD evaluated and the oscillator trim frequencies indicating a strongest acoustic wave are selected. The oscillators on both IMDs are set to the selected oscillator trim frequencies.
Still other embodiments will become readily apparent to those skilled in the art from the following detailed description, wherein are described embodiments of the invention by way of illustrating the best mode contemplated for carrying out the invention. As will be realized, the invention is capable of other and different embodiments and its several details are capable of modifications in various obvious respects, all without departing from the spirit and the scope of the present invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not as restrictive.
Although described in relation to medical devices intended for providing cardio and cardiopulmonary diagnosis, therapy, or monitoring, the embodiments described apply generally to all implantable medical devices and sensors capable of wireless intracorporeal interconnection and remotely interrogated or programmed.
Recent advances in microelectronics have made direct IMD-to-IMD, including IMD-with-implantable sensor, intercommunications via wireless acoustic telemetry commercially practicable.
By way of example, a therapeutic IMD 12, such as a cardiac therapy device, is paired with a monitoring IMD 14, such as a cardiac monitoring device. Cardiac therapy devices include pacemakers, implantable cardioverter-defibrillators, biventricular pacemakers, and similar devices. The therapeutic IMD 12 is surgically implanted in the chest, abdomen, or other internal bodily location of a patient 10 and includes physically attached components, such as leads 13 for providing monitoring within and for delivering therapy to the patient's heart 11. The monitoring IMD 14 is deployed intravascularly through a catheter into the left coronary artery or other internal bodily location, or implanted in similar fashion as the therapeutic IMD 12. The monitoring IMD 14 is self-contained and may not be intended for surgical access or removal. Other forms of IMD and components are possible.
Each IMD 12, 14 encloses operational circuitry within a hermetically-sealed housing. Referring to the therapeutic IMD 12, the operational circuitry generally includes a transducer 15; oscillator 16; control circuitry 17; memory 18; and power source 19, which provides a finite power supply for the operational circuitry. The monitoring IMD 14 also includes operational circuitry such as a transducer 15 a and oscillator 16 a, as further shown, for example, in
In a further embodiment, the patient data can be evaluated, either by an IMD 12, 14, or an external device, for the occurrence of one or more chronic or acute health conditions, such as described in related, commonly-owned U.S. Pat. No. 6,336,903, to Bardy, issued Jan. 8, 2002; U.S. Pat. No. 6,368,284, to Bardy, issued Apr. 9, 2002; U.S. Pat. No. 6,398,728, to Bardy, issued Jun. 4, 2002; U.S. Pat. No. 6,411,840, to Bardy, issued Jun. 25, 2002; and U.S. Pat. No. 6,440,066, to Bardy, issued Aug. 27, 2002, the disclosures of which are incorporated by reference.
In a still further embodiment, the patient data is extracorporeally safeguarded against unauthorized disclosure to third parties, including during collection, assembly, evaluation, transmission, and storage, to protect patient privacy and comply with recently enacted medical information privacy laws, such as the Health Insurance Portability and Accountability Act (HIPAA) and the European Privacy Directive. At a minimum, patient health information that identifies a particular individual with health- and medical-related information is treated as protectable, although other types of sensitive information in addition to or in lieu of specific patient health information could also be protectable.
Oscillator and Transducer Frequency Trim
In general, an oscillator regulates the timing of operations performed by digital components within an IMD, which has a direct affect on the operation of a transducer.
As required, to restore transducer efficiency and synchrony, the oscillator 16 must be trimmed.
The transducer 15 has a response based on the frequency of the exciting signal.
Over time, the transducer's output response curve can change.
The transducers for a pair of IMDs can be safely and efficiently trimmed by performing a sweep through their respective oscillator trim frequency ranges. The trim frequency ranges can be mapped heuristically.
Referring first to
Upon completion of the sweep, the initiating IMD evaluates the responses received from the responding IMD during each iteration and selects a new combination of oscillator trim frequencies for both of the IMDs (step 68). The new oscillator trim frequencies are selected based on the strongest acoustic wave observed, which could be indirectly indicated by the number of responses that the initiating IMD successfully received back from the responding IMD by directly reading the signal-to-noise ratio, or by making other quantitative measurement of signal strength. For instance, a suboptimal oscillator trim frequency pairing might result in only a few of the commands being successfully received by the responding IMD, or in a low signal-to-noise ratio. The responding IMD would respond to the received commands, yet the suboptimal frequency pairing might also result in even fewer responses being successfully received by the initiating IMD. A frequency pairing exhibiting higher rates of command and response receipts would indicate a stronger acoustic wave, or a high signal-to-noise ratio. Other oscillator trim frequency selection criteria are possible. The new oscillator trim frequency is sent to the responding IMD (step 69). Similarly, the new oscillator trim frequency for the initiating IMD is set and saved (step 70), after which transducer trimming is complete.
Referring next to
Upon completion of the sweep, the responding IMD waits to receive a new oscillator trim frequency from the initiating IMD (step 88). Upon receipt, the new oscillator trim frequency for the responding IMD is set and saved into volatile memory (step 89), after which transducer trimming is complete.
As the new oscillator trim frequency is stored in volatile memory, the new frequency is only temporarily retained. A reference oscillator trim frequency for the oscillator 16 is permanently maintained in the non-volatile memory. Thus, should the new oscillator trim frequency prove too aggressive or ineffective, thereby resulting in loss of communications or device error, the reference oscillator trim frequency can be automatically recovered from the non-volatile memory. The volatile memory is cleared, generally by performing a device reset or by allowing the responding IMD to enter a standby or sleep mode, which causes the new oscillator trim frequency to be erased. Following erasure of the volatile memory, the responding IMD reverts back to the reference oscillator trim frequency maintained in the non-volatile memory and resumes normal operation.
In a further embodiment, the new oscillator trim frequency can later be stored into non-volatile memory upon receiving a command to permanently store the frequency. The initiating IMD will generally issue the command to the responding IMD only after first confirming that the new oscillator trim frequency is reliable and safe and can be used without adverse effect to device operation.
Oscillator Trim Frequency Search Space Mappings
Both initiating and responding IMDs perform a sweep of possible oscillator trim frequencies to determine the best frequency pairing. The complete search space can be expressed as an n×m matrix, where there are n possible initiating IMD oscillator frequencies and there are m possible responding IMD oscillator frequencies.
Each sweep through the oscillator trim frequency search spaces simultaneously exercises the oscillators and transducers of both IMDs to enable identification of a locally optimal pairing of oscillator trim frequencies. Referring first to
An exhaustive sweep 106 tests the entire search space, but at the expense of onboard resource depletion and time. The sweep can be made more efficient by testing only a representative subset of the search space. Referring next to
Various selection criteria may apply in deciding the representative subset of the search space. For example, a search path can be mapped from an initial reference oscillator frequency pairing 115 by mapping a spiral search pattern through the search space. A spiral search pattern can be expressed in polar coordinates by selecting those oscillator frequency pairings located at a radius r specified as a continuous monotonic function of an angle θ, which is initially measured from the reference oscillator frequency pairing 115. Those oscillator frequency pairings falling within a fixed distance of the search path are selected and evaluated, thereby requiring fewer pairings to exercise the oscillators and transducers of the initiating and responding IMDs. Other search path shapes and patterns are possible.
The selective sweep 116 tests a representative part or subset of the search space, yet does not take into consideration whether the search path is producing hopeful or unpromising results. The sweep can be further improved by progressively evaluating interim oscillator trim frequency pairings. Referring to
In a further embodiment, the oscillators of the initiating and responding IMDs can be synchronized. During trimming of the transducers, oscillator frequencies may be increased or decreased based on transducer response. Actual oscillator frequencies are not measured and may be unknown due to drift.
A short command sequence can be used to synchronize the oscillators.
While the invention has been particularly shown and described as referenced to the embodiments thereof, those skilled in the art will understand that the foregoing and other changes in form and detail may be made therein without departing from the spirit and scope of the invention.
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|Clasificación de EE.UU.||607/60, 607/32|
|Clasificación cooperativa||A61N1/37288, A61N1/37217|
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|9 Ene 2009||AS||Assignment|
Owner name: CARDIAC PACEMAKERS, INC., MINNESOTA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:HUELSKAMP, PAUL;HARRIS, THOMAS J.;TRAN, BINH C.;AND OTHERS;REEL/FRAME:022083/0409;SIGNING DATES FROM 20081218 TO 20090105
Owner name: CARDIAC PACEMAKERS, INC., MINNESOTA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:HUELSKAMP, PAUL;HARRIS, THOMAS J.;TRAN, BINH C.;AND OTHERS;SIGNING DATES FROM 20081218 TO 20090105;REEL/FRAME:022083/0409
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